FDA Takes Unprecedented Step Toward Encouraging Rx-to-OTC Switch

FDA recently announced on FDAVoice that they plan to facilitate ways to encourage industry to submit an NDA for an Rx-to-OTC switch. The announcement directly addresses prescription naloxone, indicated for treatment of opioid overdose. This unusual step is consistent with FDA’s opioid action plan and is aimed at making the drug more widely available. To access the full story, click here and scroll down. For more information on Rx-to-OTC switches, click here. Meanwhile, here’s an excerpt from the story:

To help facilitate the development of OTC naloxone, the FDA has created a model DFL [Drug Facts Label] and an accompanying simple pictogram that could be placed next to the DFL to visually correspond to the label directions. This model DFL and pictogram are intended to provide consumers with the information they would need to understand how to safely use naloxone, including when it is appropriate to purchase naloxone and how to use it in an emergency opioid overdose situation. Since it is a model label, information that is highly specific to a particular product would not be included.

The FDA has also arranged for label comprehension testing of the model DFL. This testing is now being conducted and we expect that the results will yield important information about consumer understanding of the model naloxone DFL. Using this information, naloxone manufacturers may then be able to focus their final label comprehension testing on how well consumers understand product-specific information, such as instructions for the device that delivers naloxone that has not been already tested on the model DFL.